This site is intended for health professionals only!
A US court has found two of AstraZeneca’s patents valid and infringed by products produced by a rival company.
IMPAX Laboratories announced that a US district court in New York had rendered a decision in IMPAX’s patent litigation with AstraZeneca involving IMPAX’s Abbreviated New Drug Applications (ANDA) for generic Prilosec® (omeprazole) delayed-release capsules, 10mg, 20mg and 40mg.
The court has asked for additional submissions on the form of the relief, if any, in view of the fact that Astra had previously dropped its damages claim against IMPAX in order to avoid a jury trial and that the patents had expired on 20 April.
Furthermore, while the two AstraZeneca patents at issue expired on 20 April, AstraZeneca claims it is still entitled to paediatric exclusivity until 20 October and that the FDA should revoke IMPAX’s final approval until expiry of the paediatric exclusivity period. IMPAX does not believe AstraZeneca is entitled to such relief.
Pursuant to a June 2001 strategic alliance agreement, Teva Pharmaceutical Industries has US marketing rights to IMPAX’s omeprazole delayed-release capsules. In September and November 2004, Teva commenced sales of IMPAX’s 20mg and 10mg strengths, respectively.
Business Wire 4/7/2007